Aspiration needle apparatus incorporating its own vacuum and method and adapter for use therewith

ABSTRACT

An aspiration needle apparatus for collecting cell samples from tissue comprising a vacuum container having an enclosed evacuated space evacuated to a subambient pressure and sealed by a penetrable diaphragm. An adapter has a recess to receive the vacuum container. A needle is carried by the adapter and has a distal extremity serving as an aspiration needle to collect the cell sample and has a proximal extremity disposed in the recess and is capable of penetrating the diaphragm of the vacuum container to couple the evacuated space to the flow passage of the needle to supply a subambient pressure to the distal extremity of the needle. An on-off mechanism carried by the adapter includes yieldable means and a member mounted in the recess actuatable by axial movement of the vacuum container into the recess against the force of the yieldable means disposed within the recess. The on-off mechanism also includes means secured to the member for sequentially retaining the member in a rearwardmost or at rest position and a forwardmost or latched position whereby in the forwardmost or latched position the needle means penetrates the diaphragm to supply the subambient pressure in the vacuum container to the needle means and in the rearwardmost or at rest position the needle means is free of the diaphragm so that the subambient pressure is no longer supplied to the needle means.

This application is a continuation-in-part of application Ser. No.08/631,537 filed Apr. 12, 1996, now U.S. Pat. No. 5,746,724, which is acontinuation-in-part of application Ser. No. 08/504,928 filed Jul. 20,1995, now U.S. Patent No. 5,653,694, which is a continuation-in-part ofapplication Ser. No. 08/421,064 filed on Apr. 13, 1995, abandoned.

In fine needle aspiration technology, there has been a need for applyinga vacuum to the needle to accomplish the aspiration. Typically this hasbeen accomplished by use of a syringe and in certain occasions by theapplication of a vacuum to the needle by a vacuum pump under the controlof the physician performing the aspiration procedure. There is a needfor a simplified apparatus for accomplishing fine needle aspiration.

In general, it is an object of the present invention to provide anaspiration needle apparatus incorporating its own vacuum and a methodand adapter for use therewith.

Another object of the invention is to provide a removable adapter whichcan be utilized for mating an aspiration needle to a vacuum container.

Another object of the invention is to provide an apparatus and methodand adapter of the above character for use therewith which makes itpossible to readily establish a vacuum condition in the needle apparatusand to thereafter break the vacuum.

Another object of the invention is to provide an apparatus and methodand adapter of the above character in which an on-off mechanism isprovided with the adapter to facilitate the establishing of and breakingof the vacuum condition.

Another object of the invention is to provide an apparatus and methodand adapter of the above character in which the adapter is formed toreceive a vacuum container and for retaining the vacuum container sothat it will not inadvertently fall out.

Another object of the invention is to provide an adapter of the abovecharacter which can be used repeatedly.

Another object of the invention is to provide an aspiration needleapparatus of the above character in which first and second needles areprovided for first communicating with the vacuum and thereafter forbreaking the vacuum.

Another object of the invention is to provide an aspiration needleapparatus of the above character in which only a single needle isrequired.

Another object of the invention is to provide an aspiration needleapparatus and method of the above character in which the specimen cellsample can be sucked out of the needle through a second vacuum containeralong with a medium.

Another object of the invention is to provide an aspiration needleapparatus and method of the above character in which the cell samplealong with the medium can be shipped in the second vacuum container to alaboratory for analysis.

Additional objects and features of the invention will appear from thefollowing description in which the preferred embodiments are set forthin detail in conjunction with the accompanying drawings.

FIG. 1 is a side-elevational view in section of an aspiration needleapparatus incorporating its own vacuum which includes the aspirationneedle, an adapter and a vacuum container.

FIG. 2 is an enlarged cross-sectional view taken along the line 2--2 ofFIG. 1.

FIG. 3, is a cross-sectional view taken along the line 3--3 of FIG. 2.

FIG. 4 is a view similar to that shown in FIG. 1 but showing the vacuumin the vacuum container being applied to the needle.

FIG. 5 is a view similar to FIG. 4 but showing the vacuum to the needlebeing broken.

FIG. 6 is a side-elevational view in section showing an aspirationneedle with a collected cell sample in a sealed container fortransportation to a laboratory.

FIG. 7 is a side-elevational view of another embodiment of the presentinvention.

FIG. 8 is a cross sectional view taken along the lines 8--8 of FIG. 5.

FIG. 9 is a side-elevational view in section of another embodiment of anaspiration needle apparatus incorporating the present invention.

FIG. 10 is a cross sectional view taken along the line 10--10 of FIG. 9.

FIG. 11 is a side-elevational view of a small vacuum container utilizedwith the apparatus shown in FIG. 9.

FIG. 12 is a side-elevational view of a large vacuum container used withthe apparatus shown in FIG. 9.

FIG. 13 is a side-elevational view of a bottle containing a medium foruse with the apparatus shown in FIG. 9.

FIG. 14 is an illustration showing the manner in which the aspirationneedle apparatus shown in FIGS. 9 through 11 can be utilized forcollecting a cell sample in tissue as for example from a tumor in thetissue.

FIG. 15 is an illustration showing the manner in which the cell samplecollected in the needle apparatus shown in FIG. 14 is sucked out of theneedle along with a medium and into the large vacuum container shown inFIG. 12 with the medium being taken from the container shown in FIG. 13.

FIG. 16 is a side-elevational view partially in cross-section of anapparatus incorporating another embodiment of the invention utilizing anon-off mechanism in the adapter.

FIG. 17 is a cross-sectional view taken along the line 17--17 of FIG.16.

FIG. 18 is a greatly enlarged view of the on-off mechanism used in theapparatus shown in FIG. 16 taken along the line 18--18 of FIG. 17.

FIG. 19 is an isometric view of the member which is slidably mounted inthe cylindrical recess in the adapter shown in FIG. 16.

FIGS. 20A, 20B, 20C and 20D are illustrations or cartoons showing themanner in which the detent mechanism incorporating the adapter shown inFIG. 16 functions.

FIG. 21 is a plan view of a packaged apparatus incorporating anotherembodiment of the present invention which utilizes a different on-offmechanism in the adapter.

FIG. 22 is an enlarged exploded view of the adapter shown in FIG. 21.

FIGS. 23, 24, 25 and 26 are cross-sectional views taken respectivelyalong the lines 23--23, 24--24, 25--25 and 26--26 of FIG. 22.

FIG. 27 is an enlarged side-elevational view of the assembled adaptershown in FIG. 22 in an at rest position with certain portions being incross-section.

FIG. 28 is a view similar to FIG. 27 and showing imminent rotation.

FIG. 29 is a view similar to FIG. 28 and showing a latch point or highresting point.

FIG. 30 is a side-elevational view partially in cross section of anotherembodiment of an aspiration needle apparatus incorporating the presentinvention.

In general, an aspiration needle apparatus for collecting cell samplesfrom tissue comprises a vacuum container having an enclosed evacuatedspace evacuated to a subambient pressure and sealed by a penetrablediaphragm. An adapter is provided having a recess which is adapted toreceive the vacuum container. Needle means is carried by the adapter andhas a distal extremity serving as an aspiration needle to collect thecell sample. The proximal extremity of the needle means is disposed inthe recess and is capable of penetrating the diaphragm of the vacuumcontainer to couple the evacuated space to the flow passage of theneedle means to supply a subambient pressure to the distal extremity ofthe needle means. An on-off mechanism is carried by the adapter andincludes a member engaged by the vacuum container and mounted in therecess for axial movement in the recess. Yieldable means is disposedwithin the recess and engages the member and yieldably urges the memberand the vacuum container in a direction out of the recess. Detent meansis secured to the member for sequentially retaining the member in afirst forwardmost position and a second rearwardmost position. In thefirst position the needle means penetrates the diaphragm of the vacuumcontainer to supply a subambient pressure to the needle means and in thesecond position the needle means is free of the diaphragm so thatsubambient pressure is no longer supplied to the needle means.

More in particular as shown in FIGS. 1-3 of the drawings, the aspirationneedle apparatus 11 incorporating its own vacuum consists of anaspiration needle 12, a vacuum container 13 and an adapter 14 for matingthe vacuum container 13 to the aspiration needle 12.

The aspiration needle 12 is of the type described in co-pendingapplication Ser. No. 08/228,551 filed Apr. 15, 1994, now U.S. Pat. No.5,645,537, consisting of a rigid elongate tubular member 16 formed of asuitable material such as stainless steel having a length of 2 to 25centimeters and preferably various sizes of 3 cm, 6 cm, 10 cm, 15 cm and20 cm and of suitable diameters as for example 15-25 gauge for thevarious sizes and preferably 23 gauge. The rigid elongate tubular member16 is provided with proximal and distal extremities 17 and 18 in whichthe distal extremity is sharpened to form a needle point. The rigidelongate tubular member 16 is provided with a flow passage 21 extendingfrom the distal extremity 18 to the proximal extremity 17. The proximalextremity 17 is flared outwardly to provide a funnel-shaped recess 22leading into the flow passage 21.

A body 26 is mounted on the proximal extremity 17 of the rigid tubularmember 16 and is formed of a suitable transparent plastic, as forexample polycarbonate or acrylic. The body 26 is provided with proximaland distal extremities 27 and 28. The body 26 is provided with a conicalchamber 29 extending from the proximal extremity 27 to the distalextremity 28. The body 26 is provided with a spherical enlarged portion26a which circumscribes the conical chamber 29 in the region immediatelyadjacent the funnel shaped recess 22 which serves as a convex lens tomagnify that portion of the container for viewing aspirate ashereinafter described. The body 26 is provided with a hub 31 on theproximal extremity 27 that has a tapered conical recess 32 which adjoinsthe conical chamber 29. The body 26 is provided with an annular recess33 proximal of the enlarged portion 26a which is adapted to be engagedby fingers of the hand for controlling and movement of the needle for apurpose hereinafter described.

The vacuum container 13 is in the form of a vacuum bottle 36 formed of asuitable material such as glass. The glass bottle is of a conventionalconstruction and is generally cylindrical in shape and is provided witha neck 37 of reduced diameter that has been threaded to receive athreaded cap 38. The cap 38 is provided with a self-sealing diaphragm ormembrane 39 formed of a suitable self-sealing elastomeric material whichcan be readily penetrated by a conventional surgical needle. The vacuumcontainer 13 encloses an evacuated space 41 of a suitable size as forexample 5 to 30 milliliters and preferably approximately 7 to 10milliliters. The space 41 can be evacuated to a vacuum below ambient oratmospheric or a sub-ambient pressure ranging from 15" to 20" ofmercury.

The adapter 14 consists generally of a cylindrical body 46 which can beformed of a suitable material such as a transparent plastic, i.e. apolycarbonate or an acrylic. The body 46 is provided with proximal anddistal extremities 47 and 48. The distal extremity 48 is necked down asshown in FIG. 1 and is adapted to be removably mounted on the hub 31 ofthe body 26 to form a fluid-tight seal therewith. Cooperative matingmeans is provided on the proximal extremity 48 of the body 46 and on thevacuum container 13. Thus as shown in FIG. 1 the proximal extremity 47is provided with a cylindrical recess 51 which is adapted to receive thevacuum container 13. A flow passage 52 is provided extending from thecylindrical recess 51 through the distal extremity 48 so that it is incommunication with the conical recess 29 of the aspiration needle 12.

Needle means is carried by the adapter body 46 for establishing aconnection between the flow passage 52, the interior of the vacuumcontainer 13 first for supplying a vacuum to the flow passage 52 andthereafter to break the vacuum being supplied to the flow passage 52.Such needle means is shown in FIG. 1 and consists of first and secondneedles 53 and 54 formed of a suitable material such as stainless steel.As shown, the first and second needles 53 and 54 are carried by the body46 and are disposed within the passage 52. The first needle 53 ismounted in a resilient plug or block 56 frictionally retained in theflow passage 52 of the body 46 and formed of a suitable material such asplastic through which the first needle 53 extends. The first needle isprovided with a flow passage 57 which extends from a proximal sharpenedtip 58 to a distal extremity 59 extending through the plug 56 andopening into the flow passage 52 in the body 46.

The second needle 54 is provided with a proximal extremity 61 and adistal extremity 62. As shown particularly in FIGS. 1 and 2, the secondneedle 54 is sized so that it can be coaxially mounted on the exteriorof the first needle 53 and form an annular flow passage 63 extendingfrom the proximal extremity 61 to the distal extremity 62 and openinginto a chamber 66 that is defined by annular shoulders 67 and 68 andwhich is open to the atmosphere through a hole 71. As can be seen, theproximal extremity 61 of the second needle 54 is sharpened as shown andis distal of the proximal extremity 58 of the first needle 53 by asuitable distance as for example 1/2" for a purpose hereinafterdescribed. The second needle 54 is supported on the first needle 53 in asuitable manner such as by use of an adhesive or solder 72 within theannular passage 63 as shown particularly in FIG. 2.

Yieldable means in the form of a spring 76 is provided within thechamber 66 and has a larger distal or base end 77 engaging the shoulder68 and retained in engagement therein by suitable means such as anadhesive 78. The smaller or proximal end 79 of the spring 76 yieldablyengages the diaphragm or membrane 39 so as to retain the membrane ordiaphragm 39 out of engagement with the sharp end of the first needle53.

Operation and use of the aspiration needle apparatus 11 may now bebriefly described. Let it be assumed that it is desired to perform anaspiration procedure after a physician or surgeon has found a palpablebreast tumor by utilizing the. apparatus of the present invention forobtaining a cell sample from the breast tumor by withdrawing aspiratefrom the breast tumor. The apparatus 11 is assembled with the adapter 14inserted into the conical recess 32 of the needle. The vacuum container13 is disposed in the adapter 14 with the proximal extremity 58 of theneedle 53 distal of the membrane 39 as shown in FIG. 1. The surgeonusing one hand for locating the palpable breast tumor utilizes the otherhand to grasp the aspiration needle apparatus 11 by two fingers as forexample the thumb and forefinger to grasp the annular recess 33 of theaspiration needle 12 and pushes the needle to penetrate the skin of thebreast and to enter into the breast tissue and to lodge the distalextremity of the aspiration needle 12 within the tumor. As soon as thesurgeon is assured that the needle 12 is lodged into the appropriateposition with the tumor.

The surgeon or physician using the forefinger of the hand holding theaspiration needle apparatus 11 engages the vacuum container 13 andpresses it distally against the force of the spring 76 to cause relativemovement between the adapter 14 and the vacuum container 13 to a firstposition to cause the sharpened proximal extremity 58 of the firstneedle 53 to puncture the diaphragm or membrane 39 carried by thecontainer 36 to expose the evacuated space 41 to the interior flowpassage 57 of the first inner needle 53 (see FIG. 4). This in turnexposes the flow passage in the body 46 and the conical chamber 29 inthe aspiration needle 12 and the flow passage 21 in the elongate tubularmember 16 to create a sub-ambient condition within the tumor to causecells of the tumor to be withdrawn from the tumor as an aspirate intothe flow passage 21 and to bring the aspirate into the chamber 29 wherethe entrance of the aspirate into the chamber can be observed visuallythrough the magnifying lens framed by the spherical portion 26a as shownin FIG. 1.

As soon as it has been ascertained that sufficient aspirate has beendrawn into the chamber 29, the sub-ambient pressure being applied to therigid elongate tubular member can be terminated or broken by thephysician pushing the vacuum container 13 in the form of a vacuum bottle36 and additional distance proximally against the force of the yieldablespring 76 to a second position so that the second needle 54 has itsproximal extremity 61 penetrating through the diaphragm 39 as shown inFIG. 5. As soon as the proximal extremity 61 penetrates into the space41, atmospheric air can enter into the space passing through the hole 71in the body 46 and into the annular flow passage 63 in the second needle54 and into the space 41. Thus it can be seen as soon as the secondneedle 54 punctures the diaphragm 39 the sub-ambient pressure applied tothe aspiration needle 12 will be abruptly terminated so that no furtheraspirate is withdrawn from the tumor.

When the cell sample has been collected in the aspirate within thechamber 29, the aspirate remains within the chamber 29. As soon as thedesired cell sample has been collected, the aspiration needle 12 can bewithdrawn from the tumor with the adapter 14 and the vacuum container inplace. Alternatively if desired, the adapter 14 containing the vacuumcontainer 13 can be removed before withdrawing the aspiration needle 12.

Thereafter, the aspiration needle 12 can be handled in the mannerhereinbefore described in connection with the co-pending applicationSer. No. 08/228,551 filed Apr. 15, 1994, now U.S. Pat. No. 5,645,537. Asdescribed therein, the aspirate can be discharged onto slides which areshipped to laboratory for analysis or alternatively, the entire needlewith the cell sample with the aspirate therein can be supplied to thelaboratory for analysis. Thus, as shown in FIG. 6, the aspiration needle12 with the collected cell sample therein can be placed in a testtube-like container 86 formed of a suitable material such as plastic andsealed with a removable cap 87 for transportation to a laboratory foranalysis.

Another embodiment of an aspiration needle apparatus incorporating thepresent invention is shown in FIGS. 7 and 8. As shown therein, theneedle aspiration apparatus 101 consists of aspiration needle 12identical to that hereinbefore described and a vacuum container 102 andan adapter 103. As shown, the vacuum container 102 can be in the form ofa metal canister or container that is in the form of an elongatecylinder and having an internal cylindrical portion 102a disposedcoaxially therein. The cylindrical portion 102a defines a cylindricalchamber or recess 107 extending axially of the cylindrical portion 102awhich opens through an opening 108 open to the atmosphere provided inone end of the metal container 102. The other end of the cylindricalrecess 107 is open through an opening 109 into an interior evacuatedannular space 111 in the vacuum container 102 through a self-sealingdiaphragm or membrane 112 mounted therein by suitable means such as anadhesive (not shown) to close off that end of the cylindrical recess107. The cylindrical recess 107 is sized so it can serve as a femaleadapter for receiving the cylindrical male adapter 103 in the form of acylindrical body 114 formed of a suitable material such as a transparentplastic of the type hereinbefore described and is provided with theproximal and distal extremities 116 and 117. It is provided with a flowpassage 118 extending from the proximal extremity 116 to the distalextremity 117. It is also provided with an additional flow passage 119that is generally parallel to the passage 118 and extends from theproximal extremity to a point intermediate the proximal and distalextremities 116 and 117 and is in communication with a sidewiseextending port 121 that is positioned so it is always open to theatmosphere for a purpose hereinafter described.

A first needle 126 formed of a suitable material such as stainless steelwhich has a sharpened tapered proximal extremity 127 and a distalextremity 128 is disposed within the flow passage 118 and is retainedtherein in a suitable manner such as by an adhesive (not shown). Thefirst needle 126 is provided with a flow passage 129 that extends fromthe proximal extremity 127 to the distal extremity 128 of the needle andopens into the flow passage 118. Similarly, a second needle 131 having asharpened proximal extremity 132 and a distal extremity 134 is mountedwithin the body 114 by suitable means such as an adhesive (not shown).It has a flow passage 133 extending from the sharpened proximalextremity 132 to the distal extremity 134 which is in communication withthe flow passage 119 that opens to the atmosphere through the port 121as hereinbefore described. As shown in FIG. 7, the proximal extremities116 and 127 of the first and second needles 126 and 131 are staggered sothat the first needle 126 extends proximally for a suitable distance asfor example approximately 1/4 to 1/2" beyond the proximal extremity 127so that the first and second needles 126 and 131 can sequentiallypenetrate the diaphragm 112 as hereinafter described. The proximalextremity of the body 116 is tapered as shown so that it can make atight friction fit with the hub 31 of the aspiration needle 12 toprovide a fluid-tight seal therebetween.

A conical coil spring 136 is disposed within the cylindrical recess 107and is secured therein by suitable means such as an adhesive (not shown)and extends distally from the diaphragm 112 and is adapted to be engagedby the adapter 103 when it is inserted into the cylindrical recess 107.The coil spring 136 serves to prevent inadvertent puncturing of thediaphragm 112 by the first and second needles 126 and 131.

Operation and use of the aspiration needle apparatus 101 as shown inFIGS. 7 and 8 is very similar to that shown in FIG. 1 with the exceptionthat the vacuum container 13 shown in FIG. 1 is in the form of a malemember adapted to mate with an adapter 14 which is constructed as afemale member providing a chamber 66 for receiving the vacuum container13. Conversely, with the embodiment shown in FIGS. 7 and 8, the vacuumcontainer 102 is constructed as a female member having a cylindricalrecess 107 therein adapted to receive an adapter 103 which isconstructed in the form of a male member adapted to mate with thecylindrical recess 107. Thus, as can be seen in the arrangement shown inFIG. 1, the first and second needles 53 and 54 are coaxially disposedwith respect to each other whereas in the embodiment shown in FIG. 7,the first and second needles 126 and 131 are disposed side by side.

In operation of the apparatus shown in FIGS. 7 and 8, when theaspiration needle has been positioned so that the distal extremity 18 ofthe aspiration needle 12 is disposed within the tumor, the vacuumcontainer 102 can be pressed forwardly or proximally against the forceof the conical coil spring 136 to a first position to cause the proximalextremity 127 of the first needle to penetrate the diaphragm 112 and toexpose the aspiration needle 12 to the sub-ambient pressure provided inthe vacuum container 102 to cause aspirate to be drawn into the chamberof the aspiration needle 12 in the manner hereinbefore described. When asufficient sample has been collected, the vacuum container 102 can befurther depressed to cause the proximal extremity 132 of the secondneedle 132 to puncture the diaphragm to expose the evacuated space 111in the vacuum container 12 to ambient through the port 121 to break thesub-ambient condition being applied to the aspiration needle 12 tothereby terminate collection of aspirate. Thereafter, the needleaspiration apparatus 101 can be removed and the sample collected in theaspiration needle treated in the manner hereinbefore described.

It is apparent from the foregoing that there has been provided anaspiration needle apparatus 11 which facilitates collection of aspirateand cell samples as for example in tumors and the like. This collectionis enhanced because it eliminates the necessity for the physician orsurgeon doing the procedure to utilize a syringe or other vacuum sourceto create the necessary sub-ambient condition in the aspiration needle.By utilizing a pre-packaged vacuum container to supply the desiredsub-ambient condition to the needle for an appropriate period of time,the collection of the appropriate cell sample is greatly enhanced. Thusit is possible to readily collect cell samples without the necessity ofhaving a syringe or other accessory devices as for example a vacuum pumpto supply the sub-ambient condition. Also by providing a vacuumcontainer having a predetermined volume of evacuated space, it ispossible to program the sub-ambient pressure applied to the aspirationneedle 12 to also predetermine the maximum amount of time that asub-ambient pressure will be applied to the aspiration needle. Inaddition, the aspiration needle apparatus of the present invention isrelatively simple. It can be readily manufactured. If desired, it can besupplied in kit form.

Still another embodiment of the aspiration needle apparatusincorporating the present invention is shown in FIGS. 9 and 10. Theaspiration needle apparatus 151 consists of an adapter 152 which can beformed of a suitable material such as plastic. The adapter 152 consistsof a body 153 which is provided with a cylindrical bore 154 sized toreceive either a small vacuum container 156 shown in FIG. 11 or a largevacuum container 157 shown in FIG. 12. Both of the vacuum containers 156and 157 are cylindrical as shown and have basically the same diameterwith the large vacuum container 157 having a greater length than thesmall vacuum container 156. The evacuated space 158 in the small vacuumcontainer 156 can be of a suitable size as for example 5 to 30milliliters, whereas the evacuated space 159 in the large vacuumcontainer 157 can be of a suitable size as for example 30-60milliliters. These evacuated spaces are accessible by a needle which canpenetrate penetrable diaphragms 161 and 162, respectively which seal thecontainers. As shown in FIG. 9, the bore 154 in the body 153 forms acylindrical sleeve 166 into which the vacuum containers 156 and 157 canbe inserted.

Needle means 171 is carried by the body 153 of the adapter 152 and has aproximal extremity 172 which extends into the bore 154 that serves as apenetrating needle and a distal extremity 173 extending distally of thebody 153 which serves as an aspiration needle. A cell collection chamber176 is provided as a part of the needle means and is disposed betweenthe proximal and distal extremities 172 and 173 of the needle means. Itis possible that the needle means 171 be formed as a single needle of asuitable material such as stainless steel. However, in accordance withthe present invention it is preferable to form the needle means with thedistal extremity 173 being a separate aspiration needle of the typehereinbefore described and the proximal extremity 172 being formed as aseparate penetrating needle also of the type hereinbefore described.When formed as separate needles, the needles can be embedded within thebody 153 and having the flow passages therein in communication with aflow passage 181 in communication with the cell collection chamber 176which also can be formed in the tapered conical extension 182. Aspreviously disclosed, the conical extension 182 can be provided with aconvex portion 183 which surrounds the cell collection chamber 176 toprovide magnification means for viewing the cell sample collected withinthe cell collection chamber 176. Thus the flow passage in the distalextremity 173, the cell collection chamber 176 and the flow passage 181are in communication with the flow passage in the proximal extremity 172and in communication with the interior of the sleeve 166. Yieldablemeans in the form of a foam rubber disc 186 is provided within the bore154 and has a bore 187 therein through which the proximal extremity 172of the needle means 171 extends. It is generally preferable that theproximalmost extremity of the proximal extremity 172 of the needle means171 protrude slightly above the proximal surface of the yieldable means186.

The apparatus shown in FIG. 9 can be used with a medium bottle orcontainer 191 such as shown in FIG. 13 in which the medium is carriedwithin the bottle and is accessible through a cap 193 threaded onto thebottle and having a penetrable diaphragm 194 carried thereby givingaccess to the medium 192.

Operation and use of the aspiration needle apparatus shown in FIGS. 9through 13 may now be briefly described as follows. The physician picksup the adapter 152 and places the small vacuum container 156 within thebore 154 of the sleeve 166 with yieldable means 186 serving to preventthe proximal extremity 172 of the needle means 171 from penetrating thediaphragm 161. The physician, while holding the adapter 152 in one handutilizes the other hand to localize the lump which is to be analyzed andkeeps it in position while the other hand is utilized to cause thedistal extremity 173 of the needle means 171 to penetrate the lumpwithin the tissue. If desired, ultrasound can be utilized for aiding andlocating the lump to be analyzed. As shown in FIG. 15, the distalextremity 173 has been positioned within a lump 201 in tissue 202.

As soon as the distal extremity 173 of the needle means 171 has beenproperly positioned within the lump 201, the forefinger 206 of the handholding the adapter 152 can be used to urge the small vacuum container156 inwardly against the force of the yieldable means 186 to cause theproximal extremity 172 to penetrate the diaphragm 161 to establishcommunication with the evacuated space 158 and the flow passage in theneedle means so that a vacuum is supplied to the distal extremity 173disposed within the lump or tumor 201. The needle means 171 is keptsteady by the physician's index finger and thumb while maintaining thevacuum condition and the needle means 171 by the forefinger continuouslyapplying pressure to the small vacuum container 156. By holding theadapter 152 in this manner, it is possible for the physician to gentlypass the distal extremity 173 back and forth through the tumor to ensurethat an adequate cell sample has been collected which can be ascertainedby viewing the collection of the cell sample in the collection chamber166 through the magnifying bulb 183.

As soon as an adequate cell sample has been collected, the vacuum beingapplied to the needle means 171 is terminated by the forefingerreleasing the small container 156 permitting the yieldable means 186 tourge the small vacuum container 156 axially away from the proximalextremity 172 of the needle means 171. The distal extremity 173 of theneedle means 171 is then removed from the tissue 202 of the patient. Thesmall vacuum container 156 is removed from the bore 154 and the largevacuum container 157 is placed in the bore 154 of the sleeve 166 asshown in FIG. 15. The distal extremity 173 of the needle means 171 isthen covered to penetrate the diaphragm 194 of the medium container 191.As soon as the distal extremity 173 is submerged within the medium 192,the large vacuum container 157 can be pressed by the forefinger of thehand to cause the proximal extremity 172 to penetrate the diaphragm 172to couple the evacuated space to the flow passage in the needle means171 to suck up medium 192 to the flow passage into the needle means andto carry with it the cell sample collected within the collection chamber176 and to bring the collected cells along with the medium into theinterior of the vacuum container 157. As soon as the cell sample hasbeen collected from the cell collection chamber, the large vacuumcontainer 157 can be released by the forefinger permitting the yieldablemeans 186 to urge the large vacuum container off of the proximalextremity 172 of the needle means to interrupt supplying of a vacuum tothe needle means 171.

The large vacuum bottle 157 containing the cell specimen along withmedium can then be removed from the sleeve 166 and then shipped to alaboratory where the collected cells can be evaluated.

It can be seen from the foregoing that there has been provided anaspiration needle apparatus that is very simple in construction and canbe readily used for collecting cell samples. The cell sample collectedin the collection chamber of the needle means can be readily removedfrom the needle means by use of a second vacuum container and suckingthe cell collection from the collection chamber by sweeping the cellcollection out by the use of a medium also aspirated into a large vacuumcontainer for later shipment to a laboratory for analysis. Thiseliminates the need to supply a needle with the cell collection thereinto a laboratory. It also eliminates the need for a double lumen needleof the type hereinbefore described.

It should be appreciated that it is possible if there is a large enoughvacuum container available to utilize a single vacuum container forperforming the aspiration and collection functions hereinbeforedescribed by the small and large vacuum containers. However, it may beundesirable to use a single vacuum container because there is apossibility of air being introduced into the vacuum container as thecells are being collected from tissue of the patient. It can be seenthat a flow passage construction has been provided for the collection ofthe cells so that cells will not become entrapped in the needle means.Also it can be seen that the needle aspiration apparatus of the presentinvention is very simple and inexpensive and greatly facilitates thecollection of cell samples free of contamination.

In connection with the embodiment of the apparatus of the presentinvention shown in FIGS. 9-15, it has been found that the use of onefinger by the physician holding the back end of the vacuum container topush it down into engagement with the needle during the aspirationprocess may at times be awkward to the physician because that fingercannot be utilized for holding and steadying the sleeve-like adapterduring aspiration, particularly when the needle is disposed within thetumor and is being moved back and forth to collect the cell sample. Thusthere has been provided an embodiment of the invention shown in FIGS.16-20 which includes an on-off mechanism in the adapter making itpossible to establish a vacuum merely by one movement of the fingeragainst the vacuum container and which maintains this vacuum until it isdesired to terminate the vacuum, after which the vacuum bottle can beagain pressed to cause termination of the vacuum.

The aspiration needle apparatus 221 shown in FIGS. 16-20 consists of a23-gauge stainless steel needle 222 of the type hereinbefore describedin which the distal extremity is in the form of a sharpened point 223and the proximal extremity 224 is encapsulated within a body 226 formedof a suitable material such as a transparent plastic of the typehereinbefore described. The body is provided with a conical chamber 227which is provided with a taper of approximately 1.7° and a length of0.375". The chamber 227 extends into another conical chamber 228 havinga side wall extending at 5.2° and a length of 0.200". The chamber 228terminates at the proximal extremity of the needle 222. The body 226 isprovided with a generally spherical or convex portion 231 surroundingthe chamber 228 and serving as magnifying means in the mannerhereinbefore described to facilitate witnessing the collection of cellsamples as they enter into the chamber 228. The body 226 is providedwith a cylindrical protrusion 232 extending distally from the sphericalportion 231 and adjoins a smaller diameter distally extendingcylindrical protrusion 233 which is adapted to frictionally receive aprotective sleeve 236 formed of a suitable material such as transparentplastic. The sleeve 236 has a length which is longer than the length ofthe needle 222 to prevent accidental engagement with the sharpened tip223. The sleeve 236 is seated against the cylindrical protrusion 232while being frictionally retained by the cylindrical protrusion 233. ALuer-type fitting is provided on the proximal extremity of the body 226as for example a female Luer fitting 238 which is adapted to mate with acorresponding male Luer fitting 241 of an adapter 242. The adapter 242carries a cylindrical open-ended sleeve 243 which is adapted to receivea vacuum container 246 of the type hereinbefore described. A secondsharpened needle 251 of the type hereinbefore described has its distalextremity mounted within the Luer fitting 241 as shown and opens intothe Luer fitting so that when the Luer fittings 241 and 238 are mated,the flow passage in the needle 251 is in communication with the chamber227 and the flow passage within the needle 222. The proximal extremityof the needle 251 is provided with a sharpened tip 252. The vacuumcontainer 246 of the type hereinbefore described has an enclosedevacuated space evacuated to a subambient pressure sealed by apenetrable diaphragm 256 adapted to be penetrated by the needle 251.

In accordance with the present invention, an on-off mechanism, whichalso may be called a click-on click-off mechanism 261 is provided withinthe adapter 242 for controlling movement sequentially from a firstdepressed, forwardmost or "on" position and a second released,rearwardmost or "off" position. The on-off mechanism 261 consists of acircular disk 262 which is slidably mounted for axial movement withinthe cylindrical recess 263 provided in the sleeve 243. The circular disk262 is guided during its travel within the cylindrical recess 263 by adepending leg 264 formed integral therewith that extends at right anglesto the plane of the circular disk 262 and is offset from the center sothat it can travel in an elongate recess 266 provided in the wall of thesleeve 243 formed in the cylindrical recess 263. The cylindrical disk262 is provided with a hole 268 through which the needle 251 can extend.The cylindrical disk 262 is also provided with an axially extending boss269 frictionally retained in the hole 268 through which a hole 270extends. The needle 251 can freely travel through the hole 270.

The cylindrical recess 263 terminates at the bottom wall 271 whichextends at right angles to the wall forming the cylindrical recess 263and has formed integral therewith an axially extending protrusion 272centrally disposed thereon and which is provided with a bore 273 throughwhich the needle 251 extends. The protrusion or boss 272 is axiallyaligned with the boss 269 and serves for retaining opposite ends ofyieldable spring means in the form of a helical coil spring 276 thatserves to yieldably urge the disk 262 in a direction away from thebottom wall 271. The coil spring 276 has sufficient strength so thatwhen the vacuum container 246 is released by the hand depressing it, thecoil spring 276 will cause the disk 262 to move sufficiently so that theneedle 251 no longer penetrates the diaphragm 256.

On-off latch or detent means 281 forms a part of the on-off mechanism261. The on-off latch or detent means 281 takes the form of a groovedpattern 282 extending through the inwardly facing surface 283 of thedepending leg 264 carried by the disk 262. This grooved pattern 282 isengaged by a wire-like L-shaped spring member 284 having one leg 286embedded within the bottom wall 271 and having the other leg 287extending substantially at right angles thereto. The leg 287 is a muchshorter leg than the leg 286 and yieldably engages the grooved pattern282. Additional yieldable means is provided in the form of a leaf spring291 formed of a suitable material such as tempered steel. The leafspring 291 has one portion 291a which is seated on the boss 272 andanother end 291b which is inclined outwardly towards the wall formingthe cylindrical recess 263 and into engagement with the leg 286 to applyan additional yieldable spring force to maintain the leg 287 inengagement with the grooved pattern 282.

The grooved pattern 282 engaged by the leg 287 of the spring member 284as shown in FIG. 18 is in a position in which the disk 262 is in itsoutermost position with the vacuum container 246 disengaged from theneedle 251. The configuration of the grooved pattern 282 can be bestexplained in conjunction with movement of the circular disk 262 relativeto the leg 287 of the spring member 284. In the position of the leg 287shown in FIG. 18, the leg 287 is disposed in the lowermost extremity ofan inclined groove 296 to serve as stop means which prevents the disk262 from being urged outwardly through the cylindrical recess beyond apredetermined distance. As the disk 262 is depressed inwardly under theforce of the vacuum container 246, the grooved pattern 282 carried bythe leg 264 causes the leg 287 to follow and move sideways in theangularly extending groove 296 and move vertically in an adjoininggroove 297 after which it moves into another adjoining angularlyextending groove 298. However, at the transition between the groove 297and 298, there is a step 299 because the groove 298 has a depth which isgreater than the groove 297. When the container 246 is released by thehand, the spring 276 urges the disk 262 and the leg 264 carried therebyoutwardly causing the leg 287 to travel sideways towards the center ofthe grooved pattern 282 until it comes into engagement with anothergroove 301 extending at an angle as for example approximately 90° withthe groove 298. Since the groove 301 has a depth which is greater thanthe groove 298, there is a step 302 in the transition from groove 298 togroove 301 over which the leg 287 travels.

During this movement of the disk 282 under the urging of the container246, the needle 251 penetrates the membrane or diaphragm 256 of thevacuum container 246 to supply a vacuum to the needle 251 as hereinafterdescribed. Let it be assumed that it is now desired to terminate thisvacuum. Upon depression of the container 246 by the hand which causesmovement of the disk 262 with the depending leg 264 inwardly of thecylindrical recess 263, the leg 287 will travel up the groove 301. Itwill not travel up the groove 298 because it has dropped over the step302. The leg 287 moves sidewise into a groove 303. In movement of theleg 287 from the groove 301 to the groove 303, another step 304 occursbecause the groove 303 has a depth greater than the groove 301preventing the leg 287 from returning in groove 301. As the container246 is released, the coil spring 276 will urge the disk 262 outwardlyand axially in the cylindrical recess 263 causing the leg 287 to traveldownwardly along the groove 303 and thence into an adjoining angularlyextending groove 306 until it again comes into engagement with theadjoining groove 296. In moving from the groove 306 to the groove 296another step 307 is encountered at that junction because the groove 296has a depth which is greater than the depth of the groove 306, thuspreventing the leg 287 from traveling up the groove 306 when thecontainer 246 and the disk 262 are again depressed.

From the foregoing it can be seen that the grooved pattern is one thatonly permits one direction of travel of the leg 287 through the mazeprovided by the grooved pattern 282 thus assuring that when the vacuumcontainer 246 is pushed to its depressed, forwardmost or "on" position,the needle 251 will penetrate the diaphragm 256 of the vacuum container246 and be exposed to the subambient or vacuum pressure within thevacuum container 246 and retained therein when the leg 287 is disposedin the upper apex of the grooved pattern formed by the junction of thegrooves 298 and 301. The next time that the vacuum container 246 and thedisk 262 are depressed, the leg 287 moves out of the upper apex and isreleased permitting the coil spring 276 to yieldably urge the disk 262and the container 246 disposed within the sleeve 236 to be moved into areleased, rearwardmost or "off" position so that the needle 251 nolonger penetrates the diaphragm 256 and is free of the diaphragm 256thereby terminating the application of a subambient or vacuum conditionapplied to the needle 251. The leg 287 thereafter moves into the lowerapex of the grooved pattern 282 formed by the junction of grooves 306and 296. Because the on-off mechanism hereinbefore described emits anaudible sound during movements between the two apices of the on-offmechanism, it can be characterized as a click-on click-off mechanism.

Operation and use of the apparatus shown in FIGS. 16-20 may now bebriefly described as follows. In general the operation and use of theapparatus is very similar to that hereinbefore described with theprevious embodiments with the exception that the on-off mechanism 261makes it unnecessary to continue to hold the vacuum container 246 duringthe time the aspiration procedure is taking place. The needle 222 afterremoval of the protective sleeve 236 is inserted through the skin andpassed into the tumor. As soon as it has been determined that the needle222 has entered the tumor in the appropriate location, aspiration of thecells from the tumor can be commenced by supplying subambient pressureto the needle 222 by depressing the vacuum container 246 with one fingerof the hand and urging it inwardly against the force of the spring 276into the depressed, forwardmost or "on" position to cause the needle tip252 to penetrate the diaphragm 256 of the container 246 to supply thesubambient condition within the container 246 to the needle 251 whichcauses it to be supplied to the adjoining conical chambers 227 and 228and thence to the needle 222. As soon as the circular disk 262 hasreached its innermost position in the cylindrical recess 263, the vacuumcontainer 246 can be released by the hand and the latching or detentmechanism 281 serves to retain the vacuum container 246 in a first or"on" position. In order to aid in the aspiration of cells, the needle222 can be progressively moved back and forth within the tumor untilaspirated cells can be seen in the tapered chamber 228 through thespherical lens 231. As explained in co-pending application Ser. No.08/421,064 filed Apr. 23, 1995, the collection of such cell samples canbe enhanced by imparting vibratory motion to the needle 222electromechanically. By providing the detent or latching mechanism 281,the physician may remove his finger from the container 246 and utilizethat finger in conjunction with the hand to carry out the desiredmovements of the adapter 242 and the needle 222 carried thereby toenhance the cell collection.

As soon as the physician determines that sufficient collection of cellshas been obtained by observation through the spherical portion 231serving as a lens, aspiration can be terminated by utilizing a finger ofthe hand and depressing the vacuum container 246 against the force ofthe coil spring 276. This causes the leg 287 to move out of the recess301 and to move over the step 304 into the groove 302 permitting thecoil spring 276 to move the member or disk 262 to a released,rearwardmost or "off" position in which the leg 287 is seated in thegroove 296 to hold the disk 262 in the released position. As this isoccurring, the needle 251 is withdrawn from the vacuum container 246 andfrom the diaphragm 256 to break the supply of a subambient pressure tothe needle 251 and thence to the needle 222.

The aspiration needle 222 can then be removed from the patient and thecell sample collected can be treated in the manner hereinbeforedescribed. For example, it can be collected in the same or a differentvacuum container 246 as hereinbefore described by placing the aspirationneedle below the surface of a medium in another bottle. The vacuumcontainer 246 can then be depressed with a finger of the hand toreestablish the subambient pressure or vacuum condition to cause amedium in the bottle to be sucked up with the cell specimen collected inthe chambers 227 and 228. As soon as sufficient medium has been broughtthrough the needle 222 to flush the cells collected into the vacuumcontainer, the subambient pressure can be terminated by again depressingthe vacuum container 246 against the force of the spring 276 to releasethe leg 287 of the spring 284 from the upper apex of the grooved pattern282 and permitting the spring to return to the inner apex of the groovedpattern 282 and removing the needle 251 from the diaphragm 256. Thevacuum container containing the cell sample and the medium can then besent to the laboratory for analysis.

From the foregoing it can be seen that the detent or latching mechanism281 provided makes it possible for the physician using the apparatus torelease the vacuum container 246 after each operation, greatly aidingthe physician in the handling of the adapter 242 and the needle 222carried thereby to carry out the cell collection procedures.

In FIG. 21 there is shown a packaged vacuum assist aspiration biopsy kit326 which includes an aspiration needle apparatus 327 incorporatinganother embodiment of the present invention and particularlyincorporating a different on-off mechanism in the adapter than thatdisclosed in the aspiration needle apparatus 221 shown in FIGS. 16through 20 and hereinbefore described. The kit 326 also includes apackage 328 which consists of a tray 329 formed of blow moldedtransparent plastic. The tray 329 is provided with an outer rim 331 towhich there is sealed a planar sheet 332 formed of a suitable plasticwhich is capable of having ethylene oxide penetrate therethrough tosterilize the aspiration needle apparatus 327 contained therein. Thesheet 332 can also carry appropriate labeling.

The tray 329 is provided with a cavity 333 which is adapted to receivethe aspiration needle apparatus 327 as shown and to retain it thereinwhile permitting the same to be grasped by the fingers of the hand toremove the same from the cavity 333 when it is desired to use the same.Another cavity 334 is provided for receiving a vacuum container 336 foruse with the aspiration needle apparatus 327 as hereinafter described.The cavity 334 is formed so as to receive the vacuum container 336 andalso to facilitate entry of the fingers of the hand to remove the vacuumcontainer 336.

The aspiration needle apparatus 327 is very similar in many respects tothe aspiration needle apparatus 221 shown in FIGS. 16-20. The aspirationneedle apparatus 327 consists of a 23 gauge stainless steel needle 341of the type hereinbefore described in which the needle is provided witha sharpened distal extremity 342 and with a proximal extremity 343encapsulated in a transparent body 344. The body 344 is provided withchambers of the type hereinbefore described for body 226. The body 344in its proximal extremity is provided with a Luer type fitting 346 whichis adapted to receive a cylindrical protrusion 347 in a removablefriction fit with a cylindrical adapter 351. The body 344 is alsoprovided with a cylindrical protrusion 356 which has frictionallyretained thereon a cylindrical sleeve 357 formed of a suitabletransparent elastic material which covers the needle 341 as shown toprevent accidental engagement with the sharpened tip 342 of the needle.The friction fit between the protrusion 347 and the fitting 346 forms anair-tight seal between the two parts.

As shown particularly in FIG. 22, the adapter 351 is in the form of acircular disk 361 formed of a suitable material such as plastic in whichthe tapered protrusion 347 is centrally disposed and extends from oneside thereof. A cylindrical boss 362 is also centrally disposed andextends from the other side of the disk 361. The disk 361 is providedwith an annular recess 363 on its outer recess which receives one end ofa cylindrical sleeve 366 and is secured in an annular recess 367 in thesleeve 366 by suitable means such as ultrasonics. The cylindrical sleeve366 has a generally cylindrical bore 368 therein extendinglongitudinally thereof and which has mounted therein a cylindricalinsert 369 having a flange 370 sealed over the proximal end of thesleeve 366. The insert 369 is formed of a suitable material such asplastic and a precisely dimensional bore 371 therein which is open andis capable of receiving a vacuum container 372 of the same type asvacuum container 336 as shown in FIG. 21. The vacuum container 372 andvacuum container 336 typically can be in the form of a transparentplastic bottle 373 that is provided with a cylindrical removablethreaded cap 374 that carries a puncturable membrane 375 accessiblethrough a hole 376 in the cap 374. The outer cylindrical surface of thecap 374 is smooth and is sized to have a relatively close tolerance of0.001" to 0.002" with respect to the bore 368. This frictionalengagement between the cap 374 and the insert 369 is sufficient toprevent the vacuum container 372 from inadvertently dropping out evenwhen the adapter 351 is inserted while still permitting readylongitudinal or axial movement of the vacuum container 372 and theadapter 351 during operations hereinafter described.

A needle 377 is mounted in the disk 361 of the adapter 351. The needle377 can be a 23-gauge stainless steel hollow needle and has its distalextremity 378 embedded within the disk 361 which extends through theprotrusion 347 as shown in FIG. 22. The proximal extremity in the formof a sharpened tip 379 extends from the other side of the adapter disk361. As in the previous embodiments, the sharpened tip 379 is adapted topenetrate the penetrable membrane diaphragm 375 to obtain access to theclosed evacuated space provided within the vacuum container 334 whichheretofore has been evacuated to a subambient pressure.

An on-off mechanism 381 is provided within the cylindrical sleeve 366and is adapted to be engaged by the vacuum container 372 and is of thesame general type as the on-off mechanism 261 hereinbefore described andis in the form of a click-on click-off mechanism adapted to be actuatedby movement of the vacuum container 372 inwardly into the cylindricalsleeve 366 from an at rest condition, to a latched position or "on"position upon release of the vacuum container 372 and upon anotherinward movement of the vacuum container 372 from the latched position toreturn to the at rest position or "off" position upon release of thevacuum container. The details of the on-off mechanism 381 in theembodiment of the invention as shown in FIGS. 21-29 differs from theon-off mechanism 261 hereinbefore described in many respects although itoperates on the same basic principles.

The on-off mechanism 381 includes a cylindrical sleeve 366, acylindrical fixed ratchet 382, a rotating ratchet 383 and a helical coilspring 384. The helical coil spring 384 is frictionally secured to theboss 362 and extends proximally therefrom. For the on-off mechanism 381,the cylindrical sleeve 366 on the distal proximal one-half of theinterior surface thereof is provided with a plurality of spaced-apartlongitudinally and inwardly extending rib structures 391 which arespaced apart circumferentially to provide six of such rib structuresshown. As shown particularly in FIGS. 22 and 23, the rib structures 391are separated by longitudinally extending recesses 392 which extend intoa bore 393 and terminate at a ledge 394 approximately equidistant theends of the sleeve 366. The ledges 394 are formed by the tapered bore395. In the embodiment shown, six of such upstanding rib structures 391are provided to form splines within the bore 393. Each of the upstandingrib structures 391 consists of first and second spaced apart parallellongitudinally and inwardly extending side ribs 396 and 397 and anintermediate rib 398 therebetween which also forms a longitudinallyextending recess 399 because the rib 398 is of less height than the ribs396 and 397. The first rib 396 is provided with an inclined ramp surface401 which extends from the recess 392 onto a ramp surface 402 providedon the rib 398. Another inclined ramp surface 403 is provided on thedistal extremity of the rib 397.

The fixed ratchet 382 is slidably mounted in the bore 393 andcooperatively mates with the inwardly extending rib structures 391 toprevent rotational movement thereof but to permit sliding axial movementthereof. The fixed ratchet 382 is formed of a suitable material such asplastic and is provided with a cylindrical wall 406 which has a bore 407therein which is closed at one end by an end wall 408 which has acentrally disposed hole 409 and through which the needle 376 carried bythe cap or disk 361 of the adapter 351 can extend as hereinafterdescribed. A plurality of circumferentially spaced apart longitudinallyextending outwardly facing recesses 411 are provided in the cylindricalwall 406 on the exterior surface thereof to provide longitudinallyextending ribs 412 which are spaced apart to mate with the recesses 392and 398 provided on the cylindrical sleeve 366. The fixed ratchet 382 isprovided with a plurality of distally extending pointed or arrow-likeprojections 416 which are twelve in number corresponding to the twelveribs 412. The pointed projections 416 are formed integral with thecylindrical wall 406 and have an inner surface which is defined by thebore 407 and an outer surface defined by an annular recess 417. Thepointed projections 416 are separated by small axially extending slots418. Each of the pointed projections 416 is provided with parallelstraight surfaces 421 and 422 and inclined surfaces 423 and 424 whichconverge at a tip 426. The inclined surface 423 is inclined at asuitable angle as for example 60° whereas the inclined surface 424 isinclined at an angle of 45°.

The projections 416 are adapted to mate with the rotating ratchet 383.The rotating ratchet consists of a cylindrical wall 431 which has a bore432 therein with one end being closed by a recessed end wall 433 havingan outwardly extending boss 434 extending outwardly therefrom and havinga hole 436 through which the needle 376 is adapted to extend. Aplurality of outwardly and longitudinally extending projections 437 (sixin number) are circumferentially equally spaced apart on the outersurface 438 of the cylindrical wall 431. Each of the projections 437 isprovided with parallel spaced apart straight surfaces 441 and 442extending perpendicular to the outer surface 438 with an inclinedsurface 443 extending between the proximal extremities of the straightsurfaces 441 and 442 extending at an angle of approximately 45°. Theprojections 437 are also provided with inclined surfaces 444 extendingdistally from the straight surface 442 at an inclined angle ofapproximately 80°. Each projection 437 is also provided with an inwardlyextending surface 446 extending at a suitable angle as for example 60°with respect to an outer straight surface 447. The bore 432 in therotating ratchet 383 is adapted to receive the free pointed end 378 ofthe needle 396.

Operation and use of the aspiration needle apparatus 327 issubstantially identical to that hereinbefore described with theprincipal difference being in the operation of the on-off mechanism 381.The top cover 332 is removed from the kit 326 and the cylindrical sleeve366 of the aspiration needle apparatus 327 is grasped to remove theapparatus 327 from the tray 329. Because of the tight fit between thecap 374 and the insert 369, the vacuum container 372 cannot accidentallyfall out of the adapter 351. Thereafter, the sleeve 357 can be removedto expose the needle 341. Let it be assumed that the needle 341 has beenadvanced into a tumor from which it is desired to obtain a specimen inthe manner hereinbefore described. The physician holding the apparatuscan then engage the vacuum container 372 by the thumb of the hand topress the vacuum container 372 into the sleeve 366 to cause it to engagethe fixed ratchet 382 in the at rest position (see FIG. 27) and to pushit from the at rest position shown in FIG. 27 distally against therotating ratchet 383 and the yieldable force of the spring 384. Thisdistal movement of the fixed ratchet 382 causes slidable movement of thefixed ratchet 382 in the splines formed by the upstanding rib structures391 provided in the sleeve 357. This causes the 45° inclined surface 424of the fixed ratchet 382 to engage the corresponding 45° angle inclinedsurface 443 carried by the projections 437 of the rotating ratchet 383.As soon as the fixed ratchet 382 has been moved sufficiently fardistally so that the surface 424 is aligned with the cam surface 401 asshown in FIG. 28, the two surfaces 401 and 424 provide an inclined rampdown which the mating inclined surface 443 provided on the projections437 can slide under the force of the spring 384 to cause rotation of therotatable ratchet 383 in a counterclockwise direction as viewed in FIG.27. This counterclockwise rotation of rotatable ratchet 383 continuesuntil the surface 441 of the projections 437 strikes the surfaceprovided by the rib 397. At this point, the mechanism can be consideredto be at a latch point or at a high resting point (see FIG. 29).

With this position of the on-off mechanism 381, the needle 377 has beenadvanced through the rubber stopper or membrane of the vacuum container372 and vacuum has been applied to the needle 377 and when it comes tothe at rest position, the proximal extremity of the needle still iswithin the vacuum chamber of the vacuum container 372. The on-offmechanism 381 will remain in this position until it is desired toterminate the application of vacuum to the needle, at which time it ismerely necessary for the physician to again depress the vacuum container372 to again cause the vacuum container 372 to urge the fixed ratchet382 distally until the 45° inclined surface 443 carried by the rotatingratchet 383 is aligned with the inclined surface 403 provided on the rib397. The force of the spring 484 then causes the rotating ratchet 383 tobe cammed proximally and at the same time to rotate the same in acounterclockwise direction, which rotational movement continues untilthe projections 437 come into alignment with the recesses 392 betweenthe upstanding rib structures 391, permitting the rotating ratchet 383to move proximally along with the fixed ratchet 382 until the fixedratchet reaches it proximalmost position which is at the proximalmosttermination of the splines formed by the upstanding rib structures 391(see FIG. 26). In this proximalmost position or at rest position, theneedle 341 has been retracted from the vacuum container 372 to interruptthe supplying of a vacuum to the needle 341.

At the time of interruption of the vacuum it is assumed that the desiredspecimen has been collected within the vacuum bottle or container 372and the vacuum container 372 can then be removed for shipment to alaboratory for analysis as hereinbefore described. If it is desired tocollect another sample it is merely necessary to utilize the othervacuum container 336 provided in the tray 329 and to insert it into thecylindrical sleeve 366 operated in the same manner with the click-onclick-off mechanism 381 to control the application and the terminationof vacuum to the needle.

Another embodiment of the needle apparatus incorporating the presentinvention is the needle aspiration apparatus 451 shown in FIG. 30 whichis very similar to the aspiration needle apparatus 327 shown in FIGS.21-29. The aspiration needle apparatus 451 consists of a needle 341which is provided with a sharpened distal extremity 342 and is carriedby a body 344 that is provided with adjoining conical chambers 227 and228 and a spherical portion 231 serving as a lens for observation ofcell collection in the conical chamber 228. A Luer fitting 346 of aconventional type is mounted on the proximal end of the body 344.

The aspiration needle apparatus 451 also includes an adapter 351 whichis provided with a protrusion 347 as hereinbefore described. The adapter351 includes a cylindrical sleeve 366 having a bore 368 and in which acylindrical insert 369 is mounted. As in the previous embodiment, avacuum container 372 is slidably mounted within the insert 369 andconsists of a transparent plastic bottle 373 that is provided with a cap374 which carries a membrane 375 adapted to be punctured by a needle 377extending into the cylindrical protrusion 347 and opening through theprotrusion 347. An on-off mechanism 381 of the type hereinbeforedescribed in the form of a click-on/click-off mechanism is provided.

From the foregoing it can be seen that the construction of theaspiration needle apparatus 451 is substantially identical to thathereinbefore described with the principal difference being that insteadof the hub 344 being frictional retained on the protrusion 347, there isprovided a flexible elongate tubular member 456 which is provided withproximal and distal extremities 457 and 458 and in which the distalextremity 458 is tapered so that it can form an air-tight fit withrespect to the Luer fitting 346. The proximal extremity 457 is providedwith a Luer fitting 461 which is adapted to form an air-tight frictionfit with the protrusion 347.

Thus it can be seen that by providing the flexible tubular member 456,the needle 341 with its body 344 can be manipulated independently of theadapter 351 carrying the vacuum container 372. This makes it possiblefor the physician to position the needle 341 independently ofpositioning the adapter 351. The cell collection still takes place inclose proximity to the needle 341 in the body 344 and similarly thevisualization bulb provided by the spherical portion 344 is immediatelyadjacent the proximal extremity of the needle 341. In the embodimentshown in FIG. 30, it is only necessary that the vacuum condition createdby moving the vacuum container 372 so that the needle 377 penetrates themembrane 375 causes the vacuum condition to extend through the needle377 and thence through the flexible elongate tubular member 456, intothe conical chambers 227, 228 and into the needle 341.

Thus it can be seen that the needle 341 with its bulb carrying theconical chambers 227 and 228 makes it possible to collect cells withoutdamaging the cells or trapping the cells while at the same timeproviding the spherical lens for imaging purposes.

It can be seen that when desired, the flexible tubular member 456 can beremoved and the bulb 344 directly fitted onto the protrusion 347 in themanner hereinbefore described to provide a single unit that can beoperated by the physician with one hand, as hereinbefore described.Alternatively, if the physician desires, the flexible elongate tubularmember 456 can be reinserted between the adapter 351 and the body 344 tomake it possible to separately maneuver the needle 341 independent ofmovement of the adapter 351.

From the foregoing it can be seen that there has been provided anessentially auto-aspirating apparatus which includes a self-containedvacuum or subambient condition. With the apparatus of the presentinvention it is possible to visualize a specimen as it is beingcollected in the chamber therefore making it very easy to ascertain whensufficient cell specimens have been obtained. The on-off mechanism makesit easy to establish, maintain and break a vacuum.

It should be appreciated that although the present apparatus has beendiscussed in connection with palpable breast tumors, the presentapparatus can be utilized for collecting cells from non-palpable tumorsas well as collecting cells from other tissue. For example, cells can becollected to establish a baseline reference from body tissue before acancerous condition is established. When longer needles are utilized,various types of non-palpable tissue can be analyzed within the bodywith the apparatus of the present invention, as for example lungs,liver, pancreas and other organs of the body. All that is required is alonger needle.

The use of the on-off mechanism in the adapter makes it easier for theadapter and the needle carried thereby to be operated by one hand with asingle finger being periodically utilized to actuate the manual on-offmechanism to supply subambient pressure to the needle or alternativelyto break the supply of a subambient pressure to the needle. With thison-off mechanism, the apparatus is more user friendly and makes itpossible to obtain larger numbers of cells in the cell samples and toimprove the quality of cells in the cell samples. This is made possiblebecause there is no entrapping of the cell specimen in the hub of theneedle. The specimen can be readily visualized during the aspirationprocedure. The interior of the needle is smooth with no sharp edges,thereby minimizing trauma to the cells as they are collected. Inaddition, if desired, the needle with its collection chamber andvisualization means can be separated from the adapter merely byproviding an interconnecting flexible tube.

What is claimed is:
 1. An aspiration needle apparatus for collectingcell samples from tissue comprising a vacuum container having anenclosed evacuated space evacuated to a subambient pressure and sealedby a penetrable diaphragm, an adapter having a recess receiving saidvacuum container, needle means coupled to the adapter and having adistal extremity serving as an aspiration needle to collect the cellsample and having a proximal extremity disposed in said recess and beingcapable of penetrating the diaphragm of the vacuum container to couplethe evacuated space to the flow passage of the needle means to supply asubambient pressure to the distal extremity of the needle means, anon-off mechanism carried by the adapter including yieldable means and amember mounted in the recess actuatable by axial movement of the vacuumcontainer into the recess against the force of the yieldable meansdisposed within the recess, said on-off mechanism also including meanssecured to said member for sequentially retaining said member in arearwardmost or at rest position and a forwardmost or latched positionwhereby in the forwardmost or latched position the needle meanspenetrates the diaphragm to supply the subambient pressure in the vacuumcontainer to the needle means and in the rearwardmost or at restposition the needle means is free of the diaphragm so that thesubambient pressure is no longer supplied to the needle means.
 2. Anapparatus as in claim 1 together with means for rigidly securing saidneedle means to said adapter.
 3. An apparatus as in claim 1 furtherincluding a flexible elongate tubular member having proximal and distalextremities, means connecting the distal extremity to the needle andmeans connecting the proximal extremity to the adapter permitting theneedle means to be moved independently of the movement of the adapter.4. An apparatus as in claim 1 further including cooperative meanscarried by the adapter and the vacuum container for preventing thevacuum container from accidentally falling out of the adapter duringuse.
 5. An apparatus as in claim 4 wherein the cooperative means is inthe form of a tight frictional fit between the vacuum container and theadapter.
 6. An apparatus as in claim 5 wherein said adapter includes acylindrical member having a bore therein and wherein said vacuumcontainer has a cylindrical cap sized to have a relatively tight fit inthe bore while permitting axial movement of the vacuum container in thebore.
 7. Apparatus as in claim 1 wherein said needle means includes acollection chamber disposed between the proximal and distal extremitiesof the needle means.
 8. Apparatus as in claim 7 together withmagnification means carried by the needle means for magnifying theinterior of the collection chamber.
 9. Apparatus as in claim 1 whereinsaid on-off mechanism includes detent means, said detent means includinga fixed ratchet cooperative means carried by the fixed ratchet and theinterior of the sleeve for permitting axial movement of the fixedratchet within the sleeve while preventing rotation thereof, a rotatableratchet rotatably mounted in said fixed ratchet, said yieldable meansapplying a yieldable force to said rotatable ratchet to urge saidrotatable ratchet on said fixed ratchet in a radial direction out of thesleeve and cooperative cam surfaces carried by said sleeve, said fixedratchet and said rotatable ratchet whereby said rotatable ratchet can besequentially moved from said rearwardmost or at rest position to saidforwardmost or latched position and from said forwardmost or latchedposition to said rearwardmost or at rest position.
 10. Apparatus as inclaim 9 wherein said cam means is formed so that movement of saidrotatable cam is in a single direction of rotation.
 11. Apparatus as inclaim 10 wherein said cam surfaces are arranged so that the cam surfaceson the fixed ratchet and on the sleeve are formed so that when they arealigned they form an inclined ramp and the cam surfaces provided on therotatable cam are formed to mate with the inclined ramp and can traveldown the inclined ramp to cause rotation of the rotatable ratchet. 12.Apparatus as in claim 1 wherein said detent means includes a springmember having an inwardly facing leg and a grooved pattern carried bythe member and wherein said spring member has a portion thereof adaptedto seat in said grooved pattern and means for causing relative movementbetween the leg of the spring member and the grooved pattern as themember is moved in the recess.
 13. Apparatus as in claim 12 wherein saidgrooved pattern is in the form of a one-way maze permitting movement ofthe leg of the spring member in only one direction in the maze.
 14. Anadapter for use with an aspiration needle and a vacuum container forsupplying subambient pressure to the aspiration needle from the vacuumcontainer, the vacuum container having an evacuated space thereinevacuated to a subambient pressure and a puncturable diaphragm providingaccess to the evacuated space comprising a body having a cylindricalopen-ended recess therein adapted to receive the vacuum container, aneedle mounted in the body and extending into the recess axiallythereof, a member slidably mounted in the recess and adapted to beengaged by the vacuum container, means disposed within the recess andyieldably urging the member in a direction out of the recess and detentmeans connected between the member and the body permitting movementbetween first and second positions and for retaining said membersequentially in said first and second positions and in the firstposition permitting the vacuum container to engage the member andpermitting movement of the diaphragm of the vacuum container onto theneedle as the member is moved to the second position from a firstposition and thereafter in sequence upon depression of the vacuumcontainer permitting the member and the vacuum container engaging thesame to be moved to the second position with the needle out ofengagement with the diaphragm.
 15. An adapter as in claim 14 togetherwith an additional needle having a sharpened distal extremity and amating coupling carried by the proximal extremity, said adapterincluding a coupling adapted to mate with the coupling on the additionalneedle and to place the additional needle in communication with theneedle in the adapter whereby when a subambient condition is applied tothe needle in the adapter a subambient condition is also supplied to theadditional needle.
 16. A method for withdrawing aspirate from tissue ina body by the use of an aspiration needle and a vacuum container havingan evacuated space therein evacuated to a subambient pressure accessiblethrough a puncturable diaphragm, the aspiration needle having a needleand a collection chamber and a tubular member having a sharpened distalextremity and a flow passage extending from the distal extremity intothe collection chamber and an adapter having a cylindrical recesstherein adapted to receive the vacuum container, a member slidablydisposed within the recess of the adapter and engaged by the vacuumcontainer, yieldable means carried by the adapter for yieldably urgingthe member in a direction out of the recess in the adapter, detent meansconnected between the member and the body of the adapter for limitingmovement of the member between a first or at rest position and a secondor latched position and for retaining said member in either of saidfirst and second positions, a needle carried by the body of the adapterand extending inwardly into the recess and through said member andhaving a sharpened proximal extremity and a distal extremity, theadapter having a coupling through which the distal extremity of theneedle extends for mating with the coupling of the aspiration needlewhereby when a subambient condition is supplied to the needle in theadapter the subambient is supplied to the aspiration needle, the methodcomprising attaching the coupling of the aspiration needle to thecoupling of the adapter, placing the aspiration needle in a tumor fromwhich a cell sample is to be collected, moving the vacuum container tourge the member of the adapter against the force of the yieldable meansto move the detent means to a second or latched position and to causethe needle to penetrate the diaphragm of the vacuum container so that asubambient pressure is supplied to the needle whereby cells areaspirated from the tumor, and again moving the vacuum container tooperate the detent means to terminate the collection of cells permittingthe yieldable means to urge the member of the adapter to return to thefirst or at rest position and thereby causing movement of the diaphragmoff of the needle to terminate the supplying of a subambient pressure tothe aspiration needle.